Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: Intranasal Tear Neurostimulator

• Registration Number: NCT02910713
• Lead Sponsor: Allergan

Brief Summary

This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.

Detailed Description

Participants will be randomized to a single application sequence, either sequence "A" (intranasal application followed by control application) or sequence "B" (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.

Study Timeline

• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Study Start: 2016-09-30
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Results First Submitted: 2019-11-27
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-17
• Last Update Submitted: 2020-01-17
• Results First Posted: 2020-01-31
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• Moderate to severe dry eye disease
• Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
• Literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria

• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
• Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
• Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
• Corneal transplant in either or both eyes
• A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit
• Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Extranasal Application	Intranasal Tear Neurostimulator	Intranasal Tear Neurostimulator device applied extranasally (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.
Intranasal Application	Intranasal Tear Neurostimulator	Intranasal Tear Neurostimulator applied intranasally device (active), intranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.

Primary Outcome Measures

Name	Time	Method
Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)	Pre-application to Post-application on Day 0	The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to "no dryness" and 100 corresponds to "maximal dryness". A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.

Secondary Outcome Measures

Name	Time	Method
Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score	Pre-application to Post-application on Day 0	The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the eye that reached the threshold triggering the first application or if both eyes reach the threshold at the same time, the eye with the higher discomfort score or if both eyes are the same, the right eye was used. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.

Trial Locations

Locations (3)

Nashville Vision Associates; 🇺🇸 Nashville, Tennessee, United States

Eye Care Institute; 🇺🇸 Louisville, Kentucky, United States

Total Eye Care, PA; 🇺🇸 Memphis, Tennessee, United States